New York Daily News: MANHATTAN, By Kate Feldman – With omicron raging, the Food and Drug Administration has lowered the age requirement for the Pfizer booster in an effort to protect more people.
The third shot can now be given to anyone 12 or older, the FDA announced Monday, approving the emergency use authorization for the booster.
The FDA also shrunk the waiting period between the second and third shot to five months, lowered from six, to speed up the process.
“Certain” immunocompromised children, particularly those who have undergone a solid organ transplantation, between 5 and 11 years old can also get a third dose.
“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” Acting FDA Commissioner Janet Woodcock said in a statement.
“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing to in order to effectively fight COVID-19.”
During the week of Dec. 22-28, an average of 378 children ages 17 and under were hospitalized daily with COVID, according to a Centers for Disease Control and Prevention study released Thursday. That’s a 66% increase from the week before and 10% higher than the previous peak in early September.
Pfizer Albert Bourla called the FDA’s approval “critical to help us ultimately defeat this pandemic.”
“We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations,” he said in a statement.
Atleast 78 percent of people in the United States who are eligible for the vaccine have received at least one shot, according to the CDC. About 66% of eligible citizens are fully vaccinated, not including the booster.
The FDA said Monday that it studied “real-world data” from Israel, where more than 6,300 children between the age of 12 and 15 got the booster within five months of their second shot. No safety concerns arose in that data and no new cases of myocarditis or pericarditis were reported.
The news comes just as students are going back to school after winter break, despite calls to return to virtual learning as omicron cases skyrocket.
“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the delta and omicron variants. In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
“With this in mind, the FDA has extended the range of individuals eligible to receive a booster, shortened the length of time between the completion of the Pfizer primary series for individuals to receive a booster and is authorizing a third protective vaccine dose for some of our youngest and most vulnerable individuals.”